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Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014573
Recruitment Status : Completed
First Posted : April 5, 2004
Last Update Posted : April 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: filgrastim Biological: sargramostim Biological: therapeutic autologous lymphocytes Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow or peripheral blood stem cell transplantation, and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen.

OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until peripheral blood stem cell (PBSC) or bone marrow collection is completed.

After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after the last vaccination, patients undergo a second leukapheresis to collect lymphocytes.

After completion of the second leukapheresis, patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1 hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.

Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every other day for 10 days.

Patients are followed at 18, 24, 36, 40, and 52 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors
Study Start Date : August 1998
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed active recurrent or refractory primary high-grade brain tumor

    • Tumor must be surgically accessible
  • Bidimensionally measurable disease by clinical exam, CT scan, or x-ray

    • Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy
    • Previously treated metastatic bony lesions are not considered measurable
    • No previously irradiated metastatic disease site unless no response or clear progression on imaging



  • 65 and under

Performance status:

  • CALGB 0-2

Life expectancy:

  • More than 3 months


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • Liver function less than 2.5 times normal unless due to disease
  • No active hepatitis B or C


  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min


  • Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram
  • Electrocardiogram normal


  • FEV1 and DLCO greater than 50% predicted OR
  • Clearance by pulmonologist


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study
  • Able to be weaned off steroids after surgery


Biologic therapy:

  • Not specified


  • Recovered from prior conventional chemotherapy

Endocrine therapy:

  • No concurrent steroid therapy for mass effect


  • See Disease Characteristics
  • Recovered from prior conventional radiotherapy


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014573

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Esteban Abella, MD Barbara Ann Karmanos Cancer Institute
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Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00014573    
Other Study ID Numbers: CDR0000068559
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-07-92-98-P04-FB ( Other Identifier: Wayne State University - Human Investigation Committee )
First Posted: April 5, 2004    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Barbara Ann Karmanos Cancer Institute:
childhood infratentorial ependymoma
childhood supratentorial ependymoma
childhood central nervous system germ cell tumor
recurrent adult brain tumor
adult brain stem glioma
adult medulloblastoma
adult glioblastoma
childhood high-grade cerebral astrocytoma
adult anaplastic astrocytoma
childhood choroid plexus tumor
childhood grade III meningioma
adult anaplastic ependymoma
adult mixed glioma
adult central nervous system germ cell tumor
adult ependymoblastoma
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
adult choroid plexus tumor
recurrent childhood ependymoma
adult grade III meningioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents